QC Project Director – Ig Expansion (M7/M8)

CSL Plasma Inc.; Kankakee (IL); Hybrid; USD 154,000 - 193,000; Full time

Job summary

CSL Behring seeks an Associate Director, Quality Control, to provide strategic and operational leadership for QC activities supporting the M7/M8 Immunoglobulin expansion project at the Kankakee site. You will build and lead a high-performing QC organization, ensuring regulatory compliance, equipment qualification, and readiness for commercialization alongside cross-functional teams.

This role requires extensive GMP microbiology/biochemical analytics experience, strong leadership, and a proven

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry or related field; advanced degree preferred.
• 10+ years in microbiological/biochemical analytics in a GMP environment.

Responsibilities

• Provide strategic leadership for M7/8 QC activities including startup, qualification, validation, and readiness of the Ig expansion facility.
• Identify and mitigate risks impacting QC deliverables, lab readiness, testing capacity, method implementation, and qualification timelines.
• Lead QC activities supporting design reviews, user requirements, laboratory fit-out, equipment selection, and workflow optimization.
• Ensure readiness of QC activities including utilities, environmental monitoring, testing, and validation activities.
• Develop and execute operational readiness plans covering staffing, training, procedures, equipment qualification, and inventory.
• Manage QC activities by timelines, budgets, resources, and risk plans for project delivery.
• Review QC policies and perform gap assessments to improve procedures and policies.
• Establish a comprehensive QC project roadmap with milestones, budgets, risks, and deliverables.
• Provide strategic oversight of change control for analytical methods, specs, testing strategies, systems, and processes.
• Build relationships with regulatory authorities, suppliers, testing labs, consultants, and project partners.

Skills

Biology

Microbiology

Chemistry

Analytical testing

GxP regulations

Leadership

Risk management

Regulatory inspections

Education

Bachelor’s degree in a relevant scientific discipline (biology, microbiology, chemistry)

Advanced degree preferred

Tools

Analytical instruments

Job description

CSL Behring seeks an Associate Director, Quality Control, to provide strategic and operational leadership for QC activities supporting the M7/M8 Immunoglobulin expansion project at the Kankakee site. You will build and lead a high-performing QC organization, ensuring regulatory compliance, equipment qualification, and readiness for commercialization alongside cross-functional teams.

This role requires extensive GMP microbiology/biochemical analytics experience, strong leadership, and a proven